31.12.2007 14:18:00
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Third Wave Completes HPV Clinical Trial Enrollment
Third Wave Technologies Inc. (NASDAQ: TWTI) today announced that the
company has achieved the subject enrollment goals for its HPV-products
clinical trial.
The total enrollment target was comprised of 2,000 normal subjects and
1,400 women with atypical, or ASCUS, Pap test results. The next steps in
the clinical trial include obtaining the final colposcopy and biopsy
data, validating and locking down the database, opening the database,
and completing and submitting the FDA PMA applications.
"Achieving this enrollment goal marks the
completion of a major undertaking by Third Wave in the process of
seeking FDA approval of our two HPV products,”
said Kevin T. Conroy, president and chief executive of Third Wave. "We
believe that the size of our study will strengthen our FDA submissions
and the marketing of our HPV products, once they are approved.”
Third Wave anticipates making submissions to the FDA on two HPV products
during the first quarter of 2008. The two products include a test that
will screen for 14 high-risk types of HPV and a test that will enable
clinicians to determine if a patient is infected with HPV type 16 or 18,
the two most carcinogenic types.
About Third Wave Technologies
Third Wave develops and markets molecular diagnostic reagents for a
variety of DNA and RNA analysis applications to meet the needs of our
customers. The company offers a number of products based on its Invader®
chemistry for clinical testing. Third Wave offers in vitro diagnostic
kits, and analyte specific, general purpose, and research use only
reagents for nucleic acid analysis. For more information about Third
Wave and its products, please visit the company's website at www.twt.com.
All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities Exchange
Act of 1934 as amended. Such forward-looking statements are subject to
factors that could cause actual results to differ materially for Third
Wave from those projected. Those factors include risks and uncertainties
relating to the company's ability to bring new products to market as
anticipated, the current regulatory environment in which the company
sells its products, the market acceptance of those products, dependence
on partners and customers, successful performance under collaborative
and commercial agreements, competition, the strength of the Third Wave
intellectual property, the intellectual property of others and other
risk factors identified in the documents Third Wave has filed, or will
file, with the Securities and Exchange Commission. Copies of the Third
Wave filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov.
Third Wave expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward- looking statements
contained herein to reflect any change in Third Wave's expectations with
regard thereto or any change in events, conditions, or circumstances on
which any such statements are based. Third Wave Technologies, Invader
and the Third Wave logo are trademarks of Third Wave Technologies, Inc.
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